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HRS-4642 + AG
HRS-4642 + AG is a Tyrosine kinase inhibitor Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 3 development for Advanced or metastatic solid tumors (specific indication under phase 3 evaluation).
HRS-4642 is an anti-angiogenic tyrosine kinase inhibitor that blocks multiple receptor tyrosine kinases involved in tumor vascularization and growth.
HRS-4642 is an anti-angiogenic tyrosine kinase inhibitor that blocks multiple receptor tyrosine kinases involved in tumor vascularization and growth. Used for Advanced or metastatic solid tumors (specific indication under phase 3 evaluation).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | HRS-4642 + AG |
|---|---|
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Drug class | Tyrosine kinase inhibitor |
| Target | VEGFR, FGFR, and related receptor tyrosine kinases |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
HRS-4642 inhibits VEGFR, FGFR, and other kinases critical for tumor angiogenesis and proliferation. The combination with AG (likely an additional therapeutic agent) is designed to enhance anti-tumor efficacy through complementary mechanisms in phase 3 development.
Approved indications
- Advanced or metastatic solid tumors (specific indication under phase 3 evaluation)
Common side effects
- Hypertension
- Diarrhea
- Fatigue
- Proteinuria
- Hand-foot skin reaction
Key clinical trials
- A Phase III Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer (PHASE2)
- HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation (PHASE2)
- HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer (PHASE2)
- HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic Cancer (PHASE3)
- HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients (PHASE2)
- A Study of HRS-4642 in Combination With Antineoplastic Agents in Advanced Solid Tumors (PHASE1, PHASE2)
- HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- HRS-4642 + AG CI brief — competitive landscape report
- HRS-4642 + AG updates RSS · CI watch RSS
- Jiangsu HengRui Medicine Co., Ltd. portfolio CI
Frequently asked questions about HRS-4642 + AG
What is HRS-4642 + AG?
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What is HRS-4642 + AG used for?
Who makes HRS-4642 + AG?
What drug class is HRS-4642 + AG in?
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What does HRS-4642 + AG target?
Related
- Drug class: All Tyrosine kinase inhibitor drugs
- Target: All drugs targeting VEGFR, FGFR, and related receptor tyrosine kinases
- Manufacturer: Jiangsu HengRui Medicine Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors (specific indication under phase 3 evaluation)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing